pramipexole dihydrochloride

Generic: pramipexole dihydrochloride

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pramipexole dihydrochloride
Generic Name pramipexole dihydrochloride
Labeler ingenus pharmaceuticals, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pramipexole dihydrochloride .375 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-331
Product ID 50742-331_74c3457e-079c-4b2b-bae4-3f148540a27a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213444
Listing Expiration 2026-12-31
Marketing Start 2022-03-10

Pharmacologic Class

Classes
dopamine agonists [moa] nonergot dopamine agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742331
Hyphenated Format 50742-331

Supplemental Identifiers

RxCUI
901534 901541 901546 901550 901555 1114479 1114485
UPC
0350742337309 0350742336302 0350742334308 0350742335305
UNII
3D867NP06J

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pramipexole dihydrochloride (source: ndc)
Generic Name pramipexole dihydrochloride (source: ndc)
Application Number ANDA213444 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .375 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-331-30)
source: ndc

Packages (1)

50742-331-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-331-30)

Ingredients (1)

pramipexole dihydrochloride (.375 mg/1)

Linked Drug Pages (1)

Pramipexole dihydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "74c3457e-079c-4b2b-bae4-3f148540a27a", "openfda": {"upc": ["0350742337309", "0350742336302", "0350742334308", "0350742335305"], "unii": ["3D867NP06J"], "rxcui": ["901534", "901541", "901546", "901550", "901555", "1114479", "1114485"], "spl_set_id": ["1d2b1d2c-ae22-424a-bad7-ce24a817b042"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-331-30)", "package_ndc": "50742-331-30", "marketing_start_date": "20220310"}], "brand_name": "Pramipexole dihydrochloride", "product_id": "50742-331_74c3457e-079c-4b2b-bae4-3f148540a27a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "50742-331", "generic_name": "Pramipexole dihydrochloride", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pramipexole dihydrochloride", "active_ingredients": [{"name": "PRAMIPEXOLE DIHYDROCHLORIDE", "strength": ".375 mg/1"}], "application_number": "ANDA213444", "marketing_category": "ANDA", "marketing_start_date": "20220310", "listing_expiration_date": "20261231"}